Unique Device Identification (UDI)

A worldwide system for unique identification of medical devices is introduced with European regulation (EU) 2017/745 on medical devices and (EU) 2017/746 on in vitro diagnostics (IVDR). It is based on the UDI (unique device identifier), a generic term for product recognition from basic UDI, UDI-DI and UDI-PI. The basic UDI is the main key for grouping those products of a manufacturer that have the same properties. The UDI-DI (UDI Device Identifier) is a product identifier that must be assigned to the product itself or its pack. The UDI-PI (UDI Production Identifier) contains product information such as batch number or expiry date.

The following contents are available:

• IFA GmbH as UDI Issuing Entity
• Prerequesite for using the PPN as UDI-DI
• Issuing of the UDI-DI
• BUDI Generator
• HPC Generator